J&J(JNJ)
Search documents
Johnson & Johnson seeks first European Medicines Agency approval for icotrokinra aiming to transform the plaque psoriasis treatment paradigm
The Manila Times· 2025-09-11 12:07
Core Insights - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for icotrokinra, a first-in-class investigational oral peptide targeting the IL-23 receptor for treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][2][4]. Group 1: Clinical Development and Efficacy - The application is based on data from four Phase 3 studies, including ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2, which met all primary and co-primary endpoints [1][6][8]. - Icotrokinra demonstrated significant skin clearance and a favorable safety profile, achieving co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and Psoriasis Area and Severity Index (PASI) 90 compared to placebo [6][7][13]. - The ICONIC-ADVANCE studies showed superiority of icotrokinra over deucravacitinib in patients with moderate-to-severe psoriasis [1][6][13]. Group 2: Safety Profile - Pooled safety data indicated that 49.1% of patients treated with icotrokinra experienced adverse events, compared to 51.9% in the placebo group, with no new safety signals identified [1][6][8]. - The safety profile of icotrokinra is considered favorable relative to comparators, supporting its potential as a treatment option [2][4]. Group 3: Future Studies and Research - Johnson & Johnson has initiated the Phase 3 ICONIC-ASCEND study, which aims to demonstrate the superiority of icotrokinra compared to the injectable biologic ustekinumab and placebo [4][10]. - Long-term data from the ICONIC development program, including at least 52 weeks of treatment, is being prepared for future presentations [6][8]. Group 4: Market Context - Plaque psoriasis affects approximately 6.4 million people in Europe and over 125 million globally, with nearly one-quarter of cases classified as moderate-to-severe [9][10]. - The burden of plaque psoriasis extends beyond physical symptoms, impacting emotional health and quality of life [9][10].
Dr Reddy's inks pact with Johnson & Johnson to acquire vertigo treatment brand
The Economic Times· 2025-09-11 06:17
Core Insights - Dr. Reddy's Laboratories has completed the acquisition of the Stugeron brand from Johnson & Johnson, which includes markets in EMEA, India, and Vietnam [1] - This acquisition enables Dr. Reddy's to enhance its presence in the anti-vertigo market and strengthen its Central Nervous System portfolio [1] - The company plans to expand Stugeron's availability across 18 key markets, aligning with its strategic growth objectives [1]
Dr Reddy’s enters anti-vertigo segment with acquisition of Stugeron from Johnson & Johnson
BusinessLine· 2025-09-11 05:27
Core Insights - Dr. Reddy's Laboratories has completed a definitive transaction with Johnson & Johnson to acquire Stugeron Forte and Stugeron Plus across 18 markets in the APAC and EMEA regions, with India and Vietnam as key markets [1][5] - The acquisition allows Dr. Reddy's to strengthen its position in the anti-vertigo market, where Stugeron already holds a leading position in India [2][4] - The integration of the Stugeron brand and its portfolio will be managed gradually to ensure a smooth transition [3] Strategic Implications - The acquisition is part of Dr. Reddy's strategy to expand its Central Nervous System (CNS) portfolio and enhance its presence in the anti-vertigo therapeutic segment [2][4] - The company aims to leverage its strong market access to extend the reach of Stugeron and its associated products across the targeted markets [5] - Dr. Reddy's has set a goal to improve patient access and aims to reach over 1.5 billion patients by 2030 [5]
Dr Reddy’s shares slip nearly 2% on investor concerns amid $50 million foray into anti-vertigo category
The Economic Times· 2025-09-11 04:00
Core Insights - Dr. Reddy's Laboratories has signed a definitive agreement to acquire the Stugeron brand and its related portfolio from Janssen Pharmaceutica NV for $50.5 million, covering 18 markets across APAC and EMEA, with a focus on India and Vietnam [1][6]. Company Strategy - The acquisition of Stugeron, which contains the antihistamine Cinnarizine used for vestibular disorders and vertigo, will enhance Dr. Reddy's Central Nervous System (CNS) portfolio and expand its presence in the anti-vertigo therapeutic area [1][3]. - The company aims to improve patient access and reach over 1.5 billion patients by 2030, leveraging strong market access to expand Stugeron's reach across the targeted markets [3]. Financial Performance - Dr. Reddy's reported a 2% year-on-year growth in consolidated net profit at Rs 1,418 crore for the first quarter ended June, with revenue from operations increasing by 11% year-on-year to Rs 8,545 crore [5]. - The revenue growth was broad-based, supported by contributions from the acquired consumer healthcare portfolio in Nicotine Replacement Therapy (NRT) and sustained performance in branded markets [5]. Market Reaction - Following the announcement of the acquisition, Dr. Reddy's shares experienced a slight decline of 1.6% to Rs 1,283.20 on the BSE, although the shares have risen over 16% in the last six months [6].
Dr. Reddy's Acquires J&J's Stugeron Portfolio For Rs 445 Crore, Enters Anti-Vertigo Segment
NDTV Profit· 2025-09-11 02:32
Group 1 - Dr. Reddy's Laboratories Ltd. announced the acquisition of the anti-vertigo drug 'Stugeron' from Johnson & Johnson affiliate Janssen Pharmaceutica NV for $50.5 million (Rs 445 crore) [1] - The acquisition includes the 'Stugeron' brand and its key local brands Stugeron FORTE and Stugeron PLUS, along with related assets across 18 markets in the Asia-Pacific (APAC) and Europe, Middle East, and Africa (EMEA) regions, with a focus on India and Vietnam [2] - This deal will enhance Dr. Reddy's Central Nervous System (CNS) portfolio in India and emerging markets by entering the anti-vertigo segment [2] Group 2 - Stugeron contains Cinnarizine, an antihistamine used for treating vestibular disturbances and vertigo [3] - The drug is currently the market leader in the Cinnarizine segment and ranks second in the overall anti-vertigo market segment in India [3]
ClearBridge Value Strategy Q2 2025 Commentary (Mutual Fund:LMVTX)
Seeking Alpha· 2025-09-11 01:55
Market Overview - The current investment landscape appears stable but is experiencing underlying chaos due to geopolitical tensions, deglobalization, rising debt levels, and supply chain disruptions [2] - Nominal growth is faster but also more volatile and unpredictable, with companies needing to find internal resilience as external support from low interest rates and inflation diminishes [2] Structural Innovations - Innovations such as AI, blockchain, GLP-1 therapies, and decarbonization are fundamentally reshaping business growth [3] - Traditional business models, particularly in software, are threatened by AI's ability to produce similar outputs at low costs [3] Economic Shifts - The year 2025 is seen as a pivotal point marking the end of the initial phase of significant economic regime shifts, with multiple macroeconomic pillars unwinding simultaneously [5] - The U.S. Treasury is now offering meaningful yields on new debt, leading to an annual interest expense approaching $1 trillion, which presents immediate fiscal challenges [10] Supply Chain and Inflation - Governments are localizing supply chains and building strategic stockpiles, leading to inefficiencies and increased costs in infrastructure and manufacturing [11][12] - A new regime of persistent inflation is anticipated, driven by constrained supply and inelastic demand, affecting affordability for consumers and corporations [13] Corporate Performance - The ClearBridge Value Strategy outperformed its benchmark, with strong contributions from sectors like utilities and communication services, particularly benefiting from AI-related developments [19][20] - The health care sector faced challenges due to regulatory concerns and rising medical costs, impacting major companies like UnitedHealth Group [21] Portfolio Positioning - A shift towards value-oriented investments is noted, with sectors tied to industrial activity and energy production expected to benefit from infrastructure rebuilding [23] - The strategy emphasizes the importance of companies with pricing power and real assets, as traditional safe havens face valuation pressures [23] Outlook - The U.S. economy is currently supported by fiscal expansion, but concerns about sustainability are rising, with tariffs and immigration policies likely to increase inflation and reduce growth [26][27] - Opportunities are identified in real assets like gold and copper, which serve as hedges against inflation and geopolitical risks [27]
Johnson & Johnson (JNJ) Presents at Morgan Stanley 23rd Annual
Seeking Alpha· 2025-09-10 18:55
Group 1 - The presentation features Johnson & Johnson, with key executives including Chairman and CEO Joaquin Duato and Executive Vice President John Reed [1] - Terence Flynn, Morgan Stanley's U.S. biopharma analyst, is hosting the event [1]
Johnson & Johnson (JNJ) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-10 18:55
Group 1 - The presentation features Johnson & Johnson, with key executives including Chairman and CEO Joaquin Duato and Executive Vice President John Reed [1] - Terence Flynn, Morgan Stanley's U.S. biopharma analyst, is hosting the session [1]
Johnson & Johnson (NYSE:JNJ) FY Conference Transcript
2025-09-10 16:32
Johnson & Johnson FY Conference Summary Company Overview - **Company**: Johnson & Johnson (NYSE: JNJ) - **Date**: September 10, 2025 - **Speakers**: Joaquin Duato (Chairman and CEO), John Reed (Executive Vice President, Head of Pharma R&D) Key Industry Insights - **Policy Environment**: The company is actively engaging with U.S. policymakers regarding tariffs and manufacturing investments, emphasizing a $55 billion investment program over the next five years to enhance U.S. manufacturing capabilities [2][6][7]. - **Innovation Focus**: Johnson & Johnson is experiencing significant innovation, particularly in the pharmaceutical sector, with a strong pipeline in oncology, immunology, and neuroscience [3][12][13]. Core Product Developments - **Elexo Approval**: A new product, Elexo, was approved for localized bladder cancer, projected to be a $5 billion platform, with some estimates suggesting up to $8 billion potential [3][5]. - **Oncology Goals**: The company aims to become the number one oncology company by 2030, targeting $50 billion in sales, with strong growth in multiple myeloma and prostate cancer franchises [13][14]. - **Immunology Pipeline**: The focus is on Tremfya and the upcoming Icotrochimab, which is expected to be a major growth driver due to its oral administration and efficacy comparable to biologics [15][46]. Financial Performance - **Growth Trajectory**: Johnson & Johnson reported strong growth in the second quarter, exceeding expectations in both revenue and earnings per share (EPS), despite facing biosimilar competition [5][25]. - **Future Projections**: The company anticipates continued growth, with expectations that 2026 will outperform 2025, and 2027 will be better than 2026 [25]. MedTech Segment - **MedTech Strategy**: The company aims to be a leader in MedTech, focusing on high-growth markets such as cardiology and robotic surgery, with a commitment to innovation across its portfolio [30][31]. - **Cardiovascular Growth**: The cardiovascular segment saw a 22% growth in the second quarter, driven by acquisitions and innovative products [34]. Research and Development Highlights - **Alzheimer's Research**: Johnson & Johnson is investing heavily in Alzheimer's research, particularly targeting tau proteins, with ongoing phase two studies that could significantly impact treatment options [56][60]. - **Combination Therapies**: The company is exploring combination therapies in immunology, aiming to improve outcomes for patients with inflammatory bowel disease (IBD) [54][52]. Market Position and Competitive Landscape - **Community Engagement**: The company is focused on ensuring that new therapies are manageable for community oncologists, emphasizing safety and tolerability [28]. - **Business Development Focus**: Johnson & Johnson is prioritizing early-stage opportunities for significant value creation, with a history of successful smaller deals leading to major product launches [40][41]. Conclusion Johnson & Johnson is positioned for robust growth through strategic investments in innovation, a strong product pipeline, and a commitment to addressing unmet medical needs across various therapeutic areas. The company's proactive engagement with policymakers and focus on high-growth MedTech markets further solidifies its competitive edge in the industry.
Trump's Going After Prescription Drug Ads. What It Means for Pharmaceutical Sales.
Barrons· 2025-09-10 16:12
Core Viewpoint - The initiative does not completely ban advertisements but may negatively impact sales [1] Group 1 - The effort is aimed at regulating advertisements rather than imposing a total ban [1] - Potential sales impact is highlighted, suggesting that the initiative could influence consumer behavior [1]